FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
K Number: K981717
·
Decision Jun 30, 1998
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
28
Applicant Total
74
Review Days
46
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Basic Information
- Device Name
- STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
- K Number
- K981717
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Instruments
- Date Received
- May 15, 1998
- Decision Date
- June 30, 1998
- Product Code
- FTD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FTD | Lamp, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FTD), ordered by most recent decision date.
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ATRICURE DISSECTOR
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HM-LAMP II
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STRYKER KNIFELIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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